Kornimate/medical-research-clean huggingface dataset:
study to determine if different prosthetic sockets effect how much oxygen is in the tissue of lower limb amputees while they are walking

Conditions: Amputation; Diabetes Complications; Leg Injuries; Traumatic Amputation

Summary: amputee gait produces periodic occlusion of residual limb blood vessels. during the stance phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual limb and occlude blood flow. this occlusion can be relieved during swing phase, but may depend on type of prosthesis. the purpose of the proposed research is to: (1) discover the range of tissue oxygenation in the intact and residual lower limbs of dysvascular amputees during gait and (2) to learn which of five different prosthetic limb systems provides greater tissue oxygenation.

the amount of oxygen in residual limb tissue is an important health status indicator; resistance to infection, promotion of wound healing, production of collagen, and epithelialization all correlate with higher oxygen levels. unfortunately, simply donning a lower limb prosthesis may limit circulation and reduce the level of tissue oxygenation. this reduction may be compounded by the biomechanical forces of gait. the compressive loads of the body's weight during stance and the inertial loads of the prosthesis during swing may further occlude circulation, albeit by different mechanisms. for the dysvascular lower limb amputee, the choice of prosthetic socket and suspension system may impact the overall health of their residual limb and wound healing capacity. an inappropriate choice may lead to skin irritation, tissue breakdown, discomfort, and reduced mobility. for these patients, any component that reduces tissue oxygenation is a significant problem because compromised circulation can forestall wound healing. the objective of the proposed research is to use photo-oximetry to discover which of five different prosthetic limb systems results in higher residual limb tissue oxygenation during both rest and gait. this experiment will enable evidence-based decision making on this clinically relevant problem. using a prospective, randomized cross-over experimental design and the investigators' photo-oximetry system, the investigators will measure and compare the tissue oxygenation along the medial and lateral surfaces (3 sites each) of the residual limb during rest and walking.

Eligibility criteria:
inclusion criteria: all subjects must meet the following inclusion criteria: * unilateral transtibial amputee of diabetic etiology between the ages of 18 and 70, * have been fit with a prosthesis and have used a prosthesis for at least one year, * wear the prosthesis at least 4 hours per day, * ambulate without upper extremity aids, and * have no history of injurious falls within the previous six months. exclusion criteria: subjects will be excluded if: * they have a significant lower extremity pain condition, musculoskeletal disorder, or neurological deficit that interferes with their ability to pursue typical daily activities or alters their gait characteristics or * their residual limb is ulcerated.

Keywords: artificial limbs gait oximetry prosthesis rehabilitation
an observational study on predictive factors of response in patients with chronic hepatitis c treated with pegasys (peginterferon alfa-2a) and ribavirin

Conditions: Hepatitis C, Chronic

Summary: this observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis c receiving pegasys (peginterferon alfa-2a) and ribavirin. data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of treatment.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * serologically confirmed chronic hepatitis c (all genotypes) * treatment with pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (spcs)/local labelling exclusion criteria: * coinfection with hiv and/or hepatitis b * contraindications according to the spc for pegasys/ribavirin
perioperative hemodynamic and microcirculatory physiological study during tavi

Conditions: Aortic Valve Stenosis

Summary: the physiological study of haemodynamic and microcirculatory evolution before/after transcatheter aortic valve replacement (tavi) aims to investigate the physiological changes induced by the implantation of a prosthetic aortic valve on blood vessels in patients with severe aortic stenosis. the hypothesis of the study is that adaptive microcirculatory phenomena occur during tavi implantation. the results of preoperative assessment of microcirculatory functional reserve differ according to whether or not organ dysfunction occurs after tavi. there is a progressive adaptation of the microcirculation to the new cardiovascular load conditions after tavi. early features of this adaptation are associated with the occurrence of short- and medium-term complications.

this is a prospective, physiologic, monocentric, pilot cohort study carried out at the university hospitals of geneva on the initiative of the investigator. we are investigating the adaptive mechanisms at work in the blood vessels and their potential impact on clinical outcomes in the month following surgery. in addition to the usual perioperative monitoring, patients enrolled in the study will benefit from vascular monitoring, which consists of a series of additional non-invasive and painless examinations performed before, a few hours after and on the day after surgery. the clinical outcome of the aortic valve implantation will be monitored by a questionnaire on the day after the procedure, a 6-minute walk test during the usual consultation with the cardiologist on the 6th day after the procedure, and a review of patient health events one month after the valve implantation.

Eligibility criteria:
inclusion criteria: * all major patients undergoing a femoral tavi procedure for severe aortic stenosis, exclusion criteria: * non-femoral approach for tavi implantation, * presence of other concomitant severe valve disease, * planned procedure under general anesthesia, * anticipated inability to perform a 6-minute walk test post-operatively (physical handicap), * heart failure with left ventricular ejection fraction \<40%, * chronic end-stage renal failure, * chronic lung disease with home oxygen therapy, * acquired changes in serum vegf levels: recent myocardial infarction or stroke, recent vascular intervention (\< 3 months), active cancer, anti-angiogenic immunotherapy, * patients with known or identified cognitive disorders, * persons deprived of their liberty, persons under protective supervision, * pregnant or breast-feeding.

Keywords: transcatheter aortic valve implantation microcirculation endothelium, vascular microvascular reactivity
endovascular treatment with versus without intravenous rhtnk-tpa in stroke

Conditions: Stroke, Acute; Stroke, Ischemic

Summary: the purpose of this trial is to investigate whether intravenous rhtnk-tpa prior to endovascular treatment can improve 90-day functional outcome of stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of symptom onset.

the devt, skip and direct-mt trials showed that endovascular treatment alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. the extend-ia tnk part 1 and part 2 demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before endovascular treatment. however, it is unclear whether intravenous tenecteplase bridging with endovascular treatment is superior to endovascular treatment alone. the purpose of this trial is to investigate whether intravenous rhtnk-tpa bridging with endovascular treatment is better than endovascular treatment alone for stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of onset.

Eligibility criteria:
inclusion criteria: 1. aged 18 years or older; 2. patient with acute ischemic stroke who is eligible for intravenous thrombolysis treatment within 4.5 hours of time last known well; 3. no significant prestroke functional disability: for age \<80 years, prestroke modified rankin scale (mrs) ≤2; for age ≥80 years, prestroke mrs ≤1; 4. mca-m1 or -m2, basilar artery, or posterior cerebral artery-p1 occlusion proved by cta/mra; 5. evt is planned by clinical care team; 6. written informed consent is obtained from patients and/or their legal representatives. exclusion criteria: 1. intracranial hemorrhage on baseline ct or mr 2. contraindication to intravenous thrombolytics 3. already received intravenous thrombolytic after index stroke 4. known pregnancy, or breastfeeding, or serum beta human chorionic gonadotropin test is positive on admission 5. contraindication to radiographic contrast agents, nickel, titanium metals or their alloys 6. current participation in another investigational drug clinical trial 7. arterial tortuosity and/or other arterial disease that would lead to unstable access platform or prevent the thrombectomy device from reaching the target vessel 8. patient with a preexisting neurological or psychiatric disease that would confound the outcome assessments 9. patient with occlusions in two or more vascular territories (e.g. bilateral territories, or anterior and posterior circulation) 10. mass effect or intracranial neoplasm on baseline ct or mr (except small meningioma) 11. intracranial arteriovenous malformation or aneurysm on baseline ct or mr angiography 12. any terminal disease with a life expectancy less than half a year 13. unlikely to be available for follow-up at 90 days.

Keywords: thrombolysis endovascular treatment rhtnk-tpa
muscle and bone in patients with diabetes mellitus and neuropathy

Conditions: Diabetes Mellitus, Type 2; Diabetic Peripheral Neuropathy; Sarcopenia

Summary: the goal of this observational study is to evaluate muscle fiber type composition in people with type 2 diabetes mellitus (t2dm) with a common complication of t2dm: diabetic peripheral neuropathy (dnp), specifically diabetic sensorimotor polyneuropathy. researchers will also look into factors related to dnp: inflammation, the use of energy in the cell, nerve function and the tiny blood vessels in the muscle. the main question it aims to answer is: are there differences in muscle fiber type composition between persons with t2dm with and without dnp, in comparison to sex and age-matched healthy peers? participants will partake in the following tests: * electromyoneurography (emng): evaluation of nerve function, damage and repair; for diagnosis of dnp or other diseases of the nerves * blood analysis: researchers will measure insulin, blood sugar, lipid profile, inflammation * muscle biopsy in the calf (m. gastrocnemius): a doctor will take a small sample of muscle to evaluate the muscle shape and structure * mechanography: patients will perform functional tests (e.g. standing up from a chair), researchers will evaluate maximal power and maximal force of the muscles by jumping tests * questionnaires: on food intake, physical activity, smoking history, alcohol use, medical history * measurement of height, weight, and the comparison of the hip and waist circumference * peripheral quantitative computed tomography (pqct): scan of the calf for muscle density and bone density * electrocardiography (ecg): evaluation of electrical signals of the heart researchers will compare (1) patients with t2dm with dnp, (2) patients with t2dm without dnp, and (3) healthy persons to see if there are differences in muscle fiber type composition


Eligibility criteria:
inclusion criteria: all participants: * between 40-70 years of age * bmi between 18,5 - 35 kg/m2 persons with t2dm: * more than 10-year clinical diagnosis of t2dm exclusion criteria: all participants: * possible other causes of nerve impairment (vitamin b12 deficiency, excessive alcohol consumption, chemotherapy) * immobilisation (1) \> 3 months in past history or (2) \> 4 weeks in past 6 months * chronic conditions affecting the vital organs (new york heart association (nyha) 3/4, global initiative for obstructive lung disease (gold) 3/4, cystic fibrosis) * hypogonadism * inflammatory joint or intestinal diseases * chronic muscle diseases * active malignancy * malnutrition disease, eating disorder or bariatric surgery * medication use (anticoagulants, glucocorticoids, anti-androgen or anti-estrogen treatment) persons with t2dm: * insufficient control of diabetes (hba1c \>9%) healthy controls: * fasting glucose \> 100 mg/dl * hba1c \> 5.7 %
common factors group psychotherapy for general mental health concerns

Conditions: Major Depression; Generalized Anxiety; Stress Disorder, Post Traumatic; Stress; Mental Disorders

Summary: the current research will investigate the impact of general psychotherapy using common factors (i.e., techniques and communication skills that are common to all major forms of psychotherapy) to investigate whether mental health professionals can treat a variety of mental health concerns utilizing this general form of psychotherapy as opposed to specific forms of psychotherapy that may require specific trainings or education.

the current research will investigate the impact of general psychotherapy using common factors (i.e., techniques and communication skills that are common to all major forms of psychotherapy) to investigate whether mental health professionals can treat a variety of mental health concerns utilizing this general form of psychotherapy as opposed to specific forms of psychotherapy that may require specific trainings or education.

Eligibility criteria:
inclusion criteria: * at least 18 years old * experiencing self-reported psychological distress exclusion criteria: * has engaged in self-harm within the last three months * has attempted suicide within the last year * has had an active plan to attempt suicide within the last 30 days * currently diagnosed with any eating disorder * has experienced hallucinations or delusions within the last 30 days * has used narcotics within the last 7 days (heroin, meth, crack cocaine, opioids)

Keywords: common factors psychotherapy
mt1013 injection for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease

Conditions: Secondary Hyperparathyroidism (SHPT) in Subjects with Chronic Kidney Disease (CKD) on Hemodialysis

Summary: this is a randomized, positive controlled, and placebo-controlled phase ii clinical study to evaluate the efficacy and safety of mt1013 injection in the treatment of chronic kidney disease with secondary hyperparathyroidism (shpt) undergoing maintenance hemodialysis (mhd) subjects.


Eligibility criteria:
inclusion criteria: * 1. subject capable of understanding written information ,willing to participate in, and provide a written informed consent; * 2.male or female subjects must be at least 18 years old when signing the informed consent; * 3.the subjects must undergo regular maintenance hemodialysis three times a week for at least three months； * 4.dialysate calcium concentration≥1.25 mmol/l (2.5 meq/l); * 5.diagnosed of secondary hyperparathyroidism (shpt), with averaged ipth ≥400 pg/ml14 days prior to screening; * 6.receiving active vitamin d sterols must have had no more than a maximum dose change of 50% within the 1 month prior to screening, remain stable; * 7.subject receiving calcium supplements, or phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening, remain stable; exclusion criteria: * 1.the subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study; * 2.gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening; * 3.the body mass index of the subjects was less than 18kg/m2 or greater than 35 kg/m2; * 4.subjects with severe uncontrolled hypertension, defined as systolic blood pressure\>180 mmhg and/or diastolic blood pressure\>110 mmhg(except for transient blood pressure abnormalities seen during dialysis), despite optimal drug treatment prior to enrollment; * 5.history of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening; * 6.subjects with a history of malignant tumors within the past 5 years prior to screening; * 7.subjects are allergic or intolerant to any component of the investigational drug or etelcalcetide
revealed versus concealed cerebroplacental ratio

Conditions: Stillbirth

Summary: the purpose of this study is to evaluate the role of an integrated strategy at selecting fetuses for delivery at term based on a combination of fetal biometry and cerebroplacental ratio (cpr) to reduce stillbirth rate and adverse perinatal outcome.

this is a multicenter, open-label randomized trial with groups in parallel. singleton pregnancies are recruited after routine second trimester scan (19+0 to 22+6 weeks of gestation) and randomly allocated at that moment to revealed or concealed strategy. a routine scan will be booked at 36-37 weeks. for a reduction of the stillbirth rate of 3‰ (from 5‰ to 2‰), assuming a type i error of 5% and aiming for a power of 80% a total of 11,582 subjects (5791 per arm) were projected. the participating centers sum up 12,000 deliveries a year. it is not possible to blind participants, obstetricians, or outcome assessors to the study group. general hypothesis: a proportion of fetuses with "normal" growth as per current standards have placental insufficiency and restriction of their growth potential. these fetuses exhibit biophysical changes expressed by abnormal cerebroplacental ratio. a combination of this marker with fetal biometry for the detection of fetuses affected by fetal growth restriction could identify a group of babies on which labor induction once term is reached may prevent the occurrence of adverse outcomes. specific hypothesis * the cerebroplacental ratio has predictive value in late pregnancy for placental insufficiency. * the cerebroplacental ratio could improve the effectiveness of late pregnancy screening for the prediction placental insufficiency-related complications.

Eligibility criteria:
inclusion criteria: * viable singleton non-malformed fetus * available first-trimester us dating * maternal age at recruitment ≥18 years * no adverse medical or obstetrical history at booking * capacity to give informed consent exclusion criteria: * abnormal karyotype * structural abnormalities * congenital infections

Keywords: stillbirth cerebroplacental ratio fetal growth restriction
myo-inositol versus d-chiro-inositol in the treatment of polycystic ovary syndrome and insulin resistance: evaluation of clinical, metabolic, endocrine and ultrasound parameters

Conditions: PCOS

Summary: insulin resistance has important implications in the pathogenesis of the polycystic ovary syndrome (pcos) and insulin-sensitizing drugs are considered a useful therapeutic approach. reduction of insulin levels with administration of insulin sensitizing agents has been found to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring ovulation. metformin alone or in combination with oral contraceptives (ocs) has been widely used in the long term treatment of women with pcos in whom it modifies the ovarian morphology, improves intraovarian androgen levels, and enhances systemic and local insulin resistance. despite to these beneficial effects, several side effects have been reported due to the long term administration of this drug. in the recent years, inositol has found more and more space in the reproductive clinical practice. indeed, inositol have been classified as "insulin sensitizing agent" and it is mainly used as a chronic treatment for pcos. inositol exists in 9 different isomers and in particular several studies on myo-inositol and d-chiro-inositol were reported. in this study myo-inositol versus d-chiro-inositol treatments were compared to placebo in women with pcos and with or without insulin resistance.


Eligibility criteria:
inclusion criteria: * women fulfilled two out of three diagnostic criteria for pcos exclusion criteria: * women with pre-existing secondary endocrine disorders * women with personal history of hypertension, diabetes mellitus or cardiovascular disorders * women who received treatment with other drugs for the previous 6 months before entering the study.

Keywords: pcos insulin resistance myo-inositol d-chiro-inositol
mindfulness-enhanced dual-task training in pd-mci

Conditions: Mild Cognitive Impairment (MCI); Parkinson's Disease (PD)

Summary: the goal of this clinical trial is to learn if mindfulness-enhanced dual-task training work to treat pd-mci in adults. the main questions it aims to answer are: does mindfulness-enhanced dual-task training improve the cognitive or motor function of participants? can the combination of dual-task training and mindfulness achieve better effects? researchers will compare 3 groups (dual-task training + mindfulness, dual-task training, and conventional motor task training) to see if dual-task training and mindfulness works to treat pd-mci. participants will: receive treatment for 4 weeks receive scale and instrument testing before and after treatment


Eligibility criteria:
inclusion criteria: * age: between 55 and 75 years. * disease diagnosis: clinically diagnosed with idiopathic parkinson's disease (pd) according to the uk parkinson's disease society brain bank criteria. * disease stage: hoehn \& yahr (h\&y) stages 1 to 2.5. * cognitive function: montreal cognitive assessment (moca) score between 23 and 26, indicating mild cognitive impairment (mci). * medication stability: stable doses of antiparkinsonian medications for at least 4 weeks prior to screening. * subjective cognitive complaints: self-reported or informant-reported cognitive decline persisting for at least 6 months. * ambulatory ability: able to walk independently, with or without assistive devices. * sensory abilities: adequate vision and hearing to comply with study procedures. * informed consent: willingness to provide written informed consent and comply with study requirements. exclusion criteria: * other neurological disorders: presence of other neurological conditions that could affect cognitive function, such as alzheimer's disease, stroke, or brain tumors. * psychiatric conditions: severe psychiatric disorders, including major depressive disorder or schizophrenia. * substance abuse: recent history of drug or alcohol abuse. * serious medical conditions: uncontrolled hypertension, diabetes, heart disease, or other conditions that could interfere with study participation or outcomes. * severe cognitive impairment: diagnosis of parkinson's disease dementia (pdd). * other factors affecting cognition: recent head trauma, uncontrolled thyroid dysfunction, vitamin b12 deficiency, or other conditions known to affect cognitive function. * deep brain stimulation (dbs): history of dbs treatment. participation in other clinical trials: participation in another clinical trial that could interfere with this study within the last 3 months.